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Trial record 25 of 133 for:    "Paroxysmal Ventricular Fibrillation"

Evaluation of the iD‐SystemTM, One‐Handed Disposable Internal Defibrillation System. (iD-System)

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ClinicalTrials.gov Identifier: NCT04011631
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
SMART Clinical Products BV

Brief Summary:
The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Ventricular Tachycardia Procedure: Internal defibrillation during cardiac surgery, using the iD-system Not Applicable

Detailed Description:

The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

In case ventricular fibrillation occurs and the iD-system is not effective to restore the sinus trythm, the conventional approach with use of the two paddels spoons will be performed immediately.

the following will be assessed:

  • Ease of use of the device
  • Safety of the device
  • Efficacy of the device

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective interventional study with medical device.
Masking: None (Open Label)
Masking Description: The participants / patients treated in the study are blinded for the sponsor.
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : May 6, 2019
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Experimental: Patients with cardiac surgery
All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.
Procedure: Internal defibrillation during cardiac surgery, using the iD-system
When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol.




Primary Outcome Measures :
  1. Safety of the iD-System as assessed by skin symptoms [ Time Frame: During intra-thoracic procedure ]
    Safety of the iD-system will be evaluated to assess if there are skin symptoms to the electrode by confirming if irritation is visible on the back of the patient after removal of the iD elektrode or not. For the more subjects the irritation will be visible, the worse will be the safety of the iD-elektrode.

  2. Safety of the iD-System as assessed by troponin measurement [ Time Frame: During intra-thoracic procedure till 36 hours post surgery ]
    Safety of the iD-system will be evaluated via troponine measurement to assess myocardial injury. Troponine will be measured at 4, 8, 16, 24 and 36 hours post-surgery and will be reported in ng/L. A significant increase of the troponine value during these different time points indicates myocardial injury. The investigator will evaluate every case to assess if it is an Adverse Event or not.

  3. Efficacy of the iD-System as assessed via investigator questionnaire [ Time Frame: During intra-thoracic procedure ]
    Efficacy of the the iD-System will be evaluated to assess a successful restoration of the sinus rythm by counting the number of failed attempts to defibrillate which were attributable to device malfunction. This will be captured by a questionnaire, to be completed by the investigator after the surgery. A maximum of 4 shocks can be applied. If the normal arterial hearth rhythm cannot be restored after 4 shocks with the iD-System, conversion to the conventional system occurs.

  4. Ease of use of the iD-System as assessed via investigator questionnaire [ Time Frame: During intra-thoracic procedure ]

    Ease of use of the iD-System will be evaluated by a questionnaire, to be completed after the procedure. The following items will be assessed:

    • adherence of the iD-Electrode to the patient's back
    • positioning of the iD-Padde for maximal contact with the heart
    • working length of the following cables: iD-Electrode,iD-Paddle and the iD-SMART Cable

    The questionnaire will consist of 16 questions, each addressing a specific topic of the ease of use, to be scored by the investigator from 1 to 5.

    1= very poor, 2= poor, 3= neutral, 4= sufficient, 5= excellent

    The higher the total score, the better the outcome of the 'ease of use' evaluation.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All races and ethnicity (>18 years)
  • Written informed consent form (ICF) has to be obtained from the patient.
  • Elective surgery: cardiac surgery on pump (CPB)

    • Coronary artery bypass surgery
    • Heart valve repair and/or replacement

      • Mini sternotomy
      • Median sternotomy
    • Redo surgery

Exclusion Criteria:

  • Patients without cardiopulmonary bypass (referred to as heart-lung machine or pump)
  • Emergency surgery without a sufficient amount of time to explain and ask for ICF

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011631


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium, B3600
Sponsors and Collaborators
SMART Clinical Products BV
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: M. Beran, Dr. Anesthesiologist

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Responsible Party: SMART Clinical Products BV
ClinicalTrials.gov Identifier: NCT04011631     History of Changes
Other Study ID Numbers: iD-System
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes